Cornea Ectasia Excimer Laser Treatment

Sponsor

Bambino Gesù Hospital and Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04405882

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).

Condition or Disease	Intervention/Treatment	Phase
Corneal Ectasia	Procedure: topographic guided trans epithelial excimer laser

Detailed Description

Background To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia performed with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).

Methods In this retrospective study 8 eyes of 8 patients (mean age 31.50±14.73 years) affected by cornea ectasia underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were evaluated preoperatively and 6 months postoperatively using corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires.

Study Design

Study Type:

Observational

Actual Enrollment :

8 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Combined Technique of Corneal Remodeling to Treat Ectasia

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Oct 31, 2019

Actual Study Completion Date :

Apr 30, 2020

Outcome Measures

Primary Outcome Measures

quality of vision [preoperatively]
uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)
quality of vision [preoperatively]
Efficacy and Safety index.
quality of vision [preoperatively]
corneal morphological irregularity index (CMI)
quality of vision [6 months postoperatively]
uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)
quality of vision [6 months postoperatively]
Efficacy and Safety index.
quality of vision [6 months postoperatively]
corneal morphological irregularity index (CMI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 66 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

keratoconus with moderate severity (Amsler-Krumeich stage I-II)

Exclusion Criteria:

concomitant ocular disease
concomitant systemic disease
corneal opacities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Luca buzzonetti	Roma	RM	Italy	00195

Sponsors and Collaborators

Bambino Gesù Hospital and Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luca Buzzonetti, Head of the Ofthalmology Departement, Bambino Gesù Hospital and Research Institute

ClinicalTrials.gov Identifier:

NCT04405882

Other Study ID Numbers:

First Posted:

May 28, 2020

Last Update Posted:

May 28, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dilatation, Pathologic

Study Results

No Results Posted as of May 28, 2020